Physicochemical and Microbiological Stability of Ursodiol Oral Compounded Suspensions.

OBJECTIVE

In the United States, ursodiol is commercially available as solid dosage forms, which represents a problem for children who cannot swallow capsules or tablets. There is a lack of an age-appropriate formulation for ursodiol, and the extemporaneous preparation of an oral suspension with an extended beyond-use-date (BUD) may represent a good therapeutic alternative for the pediatric population. However, all pharmacists need validated stability studies to prepare oral liquids with high quality and safety.

METHODS

Oral compounded suspensions for ursodiol 20 to 60 mg/mL were prepared by adding the contents of ursodiol 300-mg commercial capsules (Actavis, KVK Tech, and Mylan) to a proprietary oral suspending vehicle. The BUD of the oral compounded suspensions was determined by using a valid, stability-indicating analytical method. The physical characterization consisted of observing all samples for appearance and color, and testing for pH. Microbiological stability testing followed the United States Pharmacopeia (USP) Chapter 51: Antimicrobial Effectiveness Testing.

RESULTS

The ursodiol oral compounded suspensions exhibited a homogeneous white color and the pH did not change significantly. The potency of the oral suspensions remained within ±10% of the specifications. Considering the microbiological characterization, there was no growth of challenge microorganisms throughout the study for all samples.

CONCLUSION

This study demonstrates that ursodiol (Actavis, KVK Tech, and Mylan) is physically, chemically, and microbiologically stable in the oral suspending vehicle at room temperature for up to 6 months.